Devices and methods for enhancing mitral valve function - Patents.com

Abstract

Devices and methods for enhancing mitral valve function are provided. The heart valve prosthetic device includes a stent frame assembly having an atrial portion and a ventricular portion, a peripheral ring attached to the stent frame assembly dividing the stent frame assembly into the atrial and ventricular portions, and a plurality of leaflets fixedly coupled to the stent frame assembly. The peripheral ring fits snugly over the native mitral valve annulus when the prosthetic device is implanted within the native mitral valve. The peripheral ring limits protrusion of the stent frame assembly into the ventricular cavity and reduces the effect of such protrusion on ventricular outflow or escape of the native leaflets.

Description

[Background technology]

[0001] (Related Applications) This application claims the benefit of Australian Provisional Application No. 2022900505, filed March 3, 2022, and Australian Provisional Application No. 2022902706, filed September 19, 2022, each of which is incorporated by reference in its entirety herein.

[0002] The mitral valve is the inlet valve for the main pumping chamber of the heart, the left ventricle. The mitral valve has two leaflets, the anterior leaflet and the posterior leaflet, both of which contribute to left ventricular function by a force feedback loop system. The anterior mitral leaflet is the most important and assists left ventricular function by resisting the force of intraventricular pressure and transmitting that force back through the left ventricular muscle to assist the pumping function of the heart. Any modification of the anterior mitral leaflet substantially impairs left ventricular function and the heart's pumping ability.

[0003] With regard to currently available bioprostheses, the complete retention of the anterior mitral leaflet at the time of mitral valve replacement is at risk of left ventricular outflow tract (LVOT) obstruction due to abnormal displacement of the native anterior mitral leaflet downwards of the aortic valve by the bioprosthesis. LVOT obstruction is associated with high mortality rates, and therefore the current standard of care is to completely remove the anterior leaflet or substantially modify it when valve replacement is performed. However, as described above, removal or modification of the anterior leaflet can substantially impair left ventricular function and cardiac pumping capacity. Therefore, an improved mitral valve bioprosthesis is desired. Summary of the Invention [Means for solving the problem]

[0004] The present disclosure relates to devices and methods for enhancing native heart valve function while accommodating the intact retention of the native heart valve leaflets without risk of ventricular outflow obstruction by the native heart valve leaflets. Aspects of the disclosure herein provide a heart valve prosthetic device. An exemplary device would typically include (i) a stent frame assembly, (ii) a peripheral ring, and (iii) a plurality of valve leaflets. The stent frame assembly has an atrial portion including an atrial-facing upper end, a ventricular portion including a ventricular-facing lower end, a height between the upper and lower ends, and a central opening that traverses between the atrial and ventricular portions. The peripheral ring is attached to the stent frame assembly and surrounds the central opening. The peripheral ring is disposed between the atrial and ventricular portions. The peripheral ring has a ventricular-facing lowermost surface configured to fit over the native mitral valve annulus when the prosthetic device is implanted within the native mitral valve. The plurality of valve leaflets are fixedly coupled to the stent frame assembly and positioned in the central opening of the stent frame assembly. The peripheral ring positions the stent frame assembly on the heart valve annulus and limits protrusion of the stent frame assembly into the ventricular cavity (e.g., the left ventricular cavity), thus reducing the effect of such protrusion on ventricular outflow or prolapse of the native cusps.

[0005] In some embodiments, the heart valve prosthetic device is a mitral valve prosthetic device. In some embodiments, the native heart valve annulus is a native mitral valve annulus. In some embodiments, the native heart valve is a native mitral valve. In some embodiments, the heart valve prosthetic device is a tricuspid valve prosthetic device. In some embodiments, the native heart valve annulus is a native tricuspid valve annulus and the native heart valve is a native tricuspid valve. In some embodiments, the ventricular length between the lowermost surface of the peripheral ring and the lower end of the stent frame assembly is less than 66% of the height between the lower and upper ends of the stent frame assembly. In some embodiments, the ventricular length between the lowermost surface of the peripheral ring and the lower end of the stent frame assembly is less than 50% of the height between the lower and upper ends of the stent frame assembly. In some embodiments, the ventricular length between the lowermost surface of the peripheral ring and the lower end of the stent frame assembly is less than 33% of the height between the lower and upper ends of the stent frame assembly. In some embodiments, the ventricular length between the lowermost surface of the peripheral ring and the lower end of the stent frame assembly is less than 8 mm. In some embodiments, the ventricular length between the lowermost surface of the peripheral ring and the lower end of the stent frame assembly is 5 mm or less. In some embodiments, the ventricular length is measured at the front side of the stent frame assembly. In some embodiments, the atrial length between the lowermost surface of the peripheral ring and the upper end of the stent frame assembly is greater than 33% of the height between the lower and upper ends of the stent frame assembly. In some embodiments, the atrial length between the lowermost surface of the peripheral ring and the upper end of the stent frame assembly is greater than 50% of the height between the lower and upper ends of the stent frame assembly. In some embodiments, the atrial length between the lowermost surface of the peripheral ring and the upper end of the stent frame assembly is greater than 66% of the height between the lower and upper ends of the stent frame assembly. In some embodiments, the height between the lower and upper ends of the stent frame assembly is measured from the front side of the stent frame assembly.In some embodiments, each leaflet comprises a flexible membrane, and the plurality of leaflets are configured to open in response to ventricular diastole and close in response to ventricular systole when the prosthetic device is implanted within the native mitral valve. In some embodiments, the plurality of leaflets are configured to allow blood flow from the atrium to the ventricle and restrict blood flow from the ventricular cavity to the atrial cavity when the prosthetic device is implanted within the native heart valve. In some embodiments, the plurality of leaflets are configured to coapt in response to blood flow from the ventricular cavity to the atrial cavity when the prosthetic device is implanted within the native heart valve. In some embodiments, the plurality of leaflets are comprised of at least partially decellularized tissue or synthetic tissue. In some embodiments, the stent frame assembly comprises a stent frame and a cover disposed over the stent frame. In some embodiments, the cover comprises fabric or pericardial tissue. In some embodiments, the stent frame assembly has a height of 12 mm to 20 mm. In some embodiments, the atrial portion has a height of 6 mm to 14 mm. In some embodiments, the ventricular portion has a height of 1.5 mm to 10 mm. In some embodiments, the peripheral ring is shaped to match the shape of the native mitral valve annulus such that the prosthetic device fits snugly over it when implanted within the native mitral valve. In some embodiments, the stent frame assembly has an anterior-posterior diameter and a transverse diameter, the anterior-posterior diameter being smaller than the transverse diameter. In some embodiments, the stent frame assembly has a leading edge, a first trailing edge, and a second trailing edge, the leading edge being flatter, longer, or flatter and longer than each of the first and second trailing edges. In some embodiments, the leading edge, the first trailing edge, and the second trailing edge of the stent frame assembly are defined by the peripheral ring. In some embodiments, the stent frame assembly has an anterior-posterior diameter of 20 mm to 34 mm. In some embodiments, the stent frame assembly has a transverse diameter of 25 mm to 39 mm. In some embodiments, the stent frame assembly is non-circular in shape. In some embodiments, the stent frame assembly is approximately D-shaped.In some embodiments, the peripheral ring is scalloped in the atrioventricular direction. In some embodiments, the peripheral ring is non-circular in shape. In some embodiments, the peripheral ring is approximately D-shaped. In some embodiments, the peripheral edges of the stent frame assembly and the peripheral ring have the same shape. In some embodiments, the peripheral ring comprises a metal wire to aid in visualization of the heart valve prosthetic device under imaging. In some embodiments, the peripheral ring comprises a leading edge, a first trailing edge, and a second trailing edge, each sized and shaped to match a complementary portion of the native valve annulus. In some embodiments, the peripheral ring further comprises a first anterior corner, a second anterior corner, and a trailing corner, the leading edge being positioned between the first and second anterior corners, the first trailing edge being positioned between the second anterior and posterior corners, and the second trailing edge being positioned between the posterior corner and the first anterior corner. In some embodiments, the leading edge is flatter, longer, or flatter and longer than each of the first and second trailing edges. In some embodiments, the plurality of leaflets includes an anterior leaflet fixedly attached to the stent frame assembly adjacent a leading edge of the peripheral ring. In some embodiments, the plurality of leaflets includes a first posterior leaflet fixedly attached to the stent frame assembly adjacent a first posterior edge of the peripheral ring and a second posterior leaflet fixedly attached to the stent frame assembly adjacent a second posterior edge of the peripheral ring. In some embodiments, the stent frame assembly comprises an asymmetric cylinder and a plurality of ventricular struts extending therefrom. In some embodiments, the peripheral ring further comprises a first anterior horn, a second anterior horn, and a posterior horn, and the plurality of ventricular struts comprises a first anterior strut positioned at the first anterior corner, a second anterior strut positioned at the second anterior corner, and a posterior strut positioned at the posterior corner. In some embodiments, the atrial end of the stent frame assembly is scalloped. In some embodiments, the ventricular end of the stent frame assembly is scalloped. In some embodiments, the peripheral ring is a sewing ring. In some embodiments, the peripheral ring is flexible in the plane of the native heart valve annulus.In some embodiments, the peripheral ring is more flexible in the plane of the native heart annulus than in a plane transverse to the plane of the native heart annulus. In some embodiments, the plurality of leaflets includes an anterior leaflet, a first posterior leaflet, and a second posterior leaflet, each of which includes a fixed edge and a free edge coupled to the stent frame assembly. In some embodiments, the anterior leaflet is larger than each of the first and second posterior leaflets. In some embodiments, the stent frame assembly includes a plurality of ventricular struts, the plurality of ventricular struts including a first anterior strut, a second anterior strut, and a posterior strut. In some embodiments, the fixed edge of the anterior leaflet is supported by the first and second anterior struts, and the distance between the first and second anterior struts exceeds the distance between each anterior and posterior strut. In some embodiments, the angle along the free edge of the anterior leaflet exceeds each angle along the free edge of the first posterior leaflet and each angle along the free edge of the second posterior leaflet. In some embodiments, the plurality of leaflets are arranged to define a first anterior commissure between adjacent free edges of the anterior leaflet and the first posterior leaflet, a second anterior commissure between adjacent free edges of the anterior leaflet and the second posterior leaflet, and a posterior commissure between adjacent free edges of the first posterior leaflet and the second posterior leaflet. In some embodiments, the heart valve prosthetic device is configured to augment a native heart valve.

[0006] Aspects of the disclosure herein also provide a method of treating a heart valve insufficiency. An exemplary method would typically include embedding a stent frame assembly of a heart valve prosthetic device into a native heart valve of the heart such that a ventricular-facing lowermost surface of a peripheral ring coupled to the stent frame assembly fits over and over the annulus of the native heart valve. The peripheral ring separates the stent frame assembly into an atrial portion and a ventricular portion. The peripheral ring limits the protrusion of the stent frame assembly into the ventricular cavity (e.g., the left ventricular cavity) and reduces the effect of such protrusion on the ventricular outflow or escape of the native cusps.

[0007] In some embodiments, the heart valve is a mitral valve. In some embodiments, the heart valve prosthetic device is a mitral valve prosthetic device. In some embodiments, the native heart valve is a native mitral valve. In some embodiments, the heart valve prosthetic device is a tricuspid valve prosthetic device. In some embodiments, the native heart valve annulus is a native tricuspid valve annulus and the native heart valve is a native tricuspid valve. In some embodiments, the ventricular length between the lowermost surface of the peripheral ring and the lower end of the stent frame assembly is less than 66% of the height between the lower and upper ends of the stent frame assembly. In some embodiments, the ventricular length between the lowermost surface of the peripheral ring and the lower end of the stent frame assembly is less than 50% of the height between the lower and upper ends of the stent frame assembly. In some embodiments, the ventricular length between the lowermost surface of the peripheral ring and the lower end of the stent frame assembly is less than 33% of the height between the lower and upper ends of the stent frame assembly. In some embodiments, the ventricular length between the lowermost surface of the peripheral ring and the lower end of the stent frame assembly is less than 8 mm. In some embodiments, the ventricular length between the lowermost surface of the peripheral ring and the lower end of the stent frame assembly is 5 mm or less. In some embodiments, the ventricular length is measured at the front side of the stent frame assembly. In some embodiments, the atrial length between the lowermost surface of the peripheral ring and the upper end of the stent frame assembly is greater than 33% of the height between the lower and upper ends of the stent frame assembly. In some embodiments, the atrial length between the lowermost surface of the peripheral ring and the upper end of the stent frame assembly is greater than 50% of the height between the lower and upper ends of the stent frame assembly. In some embodiments, the atrial length between the lowermost surface of the peripheral ring and the upper end of the stent frame assembly is greater than 66% of the height between the lower and upper ends of the stent frame assembly. In some embodiments, the height between the lower and upper ends of the stent frame assembly is measured from the front side of the stent frame assembly. In some embodiments, the heart valve prosthetic device is configured to augment a native heart valve.In some embodiments, the stent frame assembly is implanted in the native heart valve annulus with the native anterior heart valve leaflets preserved. In some embodiments, the stent frame assembly is implanted in the native heart valve annulus with the native anterior heart valve leaflets not resected or remodeled. In some embodiments, the stent frame assembly is implanted in the native heart valve annulus without substantially any change in the anatomical position of the native anterior heart valve leaflets. In some embodiments, embedding the stent frame assembly in the native heart valve includes positioning the stent frame assembly and the plurality of leaflets coupled thereto such that the native anterior leaflets of the heart valve are not hindered from occupying the annulus of the native heart valve at least partially during ventricular systole. In some embodiments, each leaflet comprises a flexible membrane, and the plurality of leaflets are configured to open in response to ventricular diastole and close in response to ventricular systole when the prosthetic device is implanted in the native heart valve. In some embodiments, the leaflets are configured to allow blood flow from the atrium to the ventricle and restrict blood flow from the ventricular cavity to the atrial cavity when the prosthetic device is implanted in the native heart valve. In some embodiments, the leaflets are configured to coapt in response to blood flow from the ventricular cavity to the atrial cavity when the prosthetic device is implanted in the native heart valve. In some embodiments, the leaflets include an anterior leaflet, a first posterior leaflet, and a second posterior leaflet, each of which includes a fixed edge coupled to the stent frame assembly and a free edge. In some embodiments, the anterior leaflet is larger than each of the first and second posterior leaflets. In some embodiments, the stent frame assembly includes a plurality of ventricular struts, the plurality of ventricular struts including a first anterior strut, a second anterior strut, and a posterior strut. In some embodiments, the fixed edge of the anterior leaflet is supported by the first and second anterior struts, and the distance between the first and second anterior struts exceeds the distance between each anterior and posterior strut. In some embodiments, the stent frame assembly comprises a stent frame and a cover disposed over the stent frame.In some embodiments, the peripheral ring is shaped to match the shape of the native heart valve annulus so that the heart valve prosthetic device fits snugly over it when implanted in the native heart valve. In some embodiments, the stent frame assembly has an anterior-posterior diameter and a horizontal diameter, the anterior-posterior diameter being smaller than the horizontal diameter. In some embodiments, the stent frame assembly has a leading edge, a first trailing edge, and a second trailing edge, the first trailing edge being flatter, longer, or flatter and longer than each of the first and second trailing edges. In some embodiments, the leading edge, the first trailing edge, and the second trailing edge of the stent frame assembly are defined by the peripheral ring. In some embodiments, the stent frame assembly is non-circular in shape. In some embodiments, the stent frame assembly is approximately D-shaped. In some embodiments, the peripheral ring is non-circular in shape. In some embodiments, the peripheral ring is approximately D-shaped. In some embodiments, the peripheral ring is scalloped in the atrioventricular direction. In some embodiments, the stent frame assembly and the peripheral edge of the peripheral ring have the same shape. In some embodiments, the stent frame assembly comprises an asymmetric cylinder and a plurality of ventricular struts extending therefrom. In some embodiments, the atrial end of the stent frame assembly is scalloped. In some embodiments, the ventricular end of the stent frame assembly is scalloped. In some embodiments, the peripheral ring is a sewing ring. In some embodiments, the peripheral ring is flexible in the plane of the heart valve annulus. In some embodiments, the peripheral ring is more flexible in the plane of the native heart valve annulus than in a plane lateral to the plane of the native heart valve annulus. [Brief description of the drawings]

[0008] The novel features of the present disclosure are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present disclosure will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the disclosure are utilized, and the accompanying drawings.

[0009] [Figure 1] FIG. 1 is a perspective view of the ventricular end of an exemplary mitral valve prosthetic device of the present disclosure, the ventricular end being configured to protrude into the ventricular cavity.

[0010] [Diagram 2] FIG. 2 is a top plan view of the mitral valve prosthetic device of FIG.

[0011] [Diagram 3] 3 is an elevational view of the mitral valve prosthetic device of FIG. 1. FIG.

[0012] [Figure 4] FIG. 4 is a perspective view of an atrial end of an exemplary mitral valve prosthetic device of the present disclosure, the atrial end being configured to protrude into the atrial cavity.

[0013] [Diagram 5] FIG. 5 is a perspective view of a stent frame of an exemplary mitral valve prosthetic device of the present disclosure.

[0014] [Figure 6] 6A-6B are elevational and cross-sectional views, respectively, of the stent frame of FIG.

[0015] [Figure 7A] 7A-7C are plan views of the stent framework of FIG. [Figure 7B] 7A-7C are plan views of the stent framework of FIG. [Figure 7C] 7A-7C are plan views of the stent framework of FIG.

[0016] [Figure 8] 8 is a cross-sectional view of an assembled mitral valve prosthetic device of the present disclosure taken along the section line indicated in FIG.

[0017] [Figure 9]9A-9B are elevational views of a stent frame of an exemplary mitral valve prosthetic device of the present disclosure depicting where a peripheral ring may be attached.

[0018] [Figure 10] FIG. 10 depicts partial and full saddle configurations of the peripheral ring of the present disclosure.

[0019] [Figure 11] FIG. 11 depicts atrialization of the mitral valve prosthetic device of the present disclosure achieved by placement of the prosthetic device on the native mitral valve annulus.

[0020] [Figure 12] 12A-12D are various views depicting a further embodiment of a mitral valve prosthetic device of the present disclosure, the prosthetic device including a peripheral ring having a scalloped edge on each ventricular strut.

[0021] [Figure 13] 13A-13B depict elevational and cross-sectional views, respectively, of a stent frame of an exemplary mitral valve prosthetic device of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0022] Unless otherwise defined, all terminology, notations, and other technical and scientific terms or terminology used herein are intended to have the same meaning as commonly understood by those skilled in the art to which the claimed subject matter pertains. In some embodiments, terms with commonly understood meanings are defined herein for clarity and / or ease of reference, and the inclusion of such definitions herein should not necessarily be interpreted as representing a substantial difference over what is generally understood in the art.

[0023] Throughout this application, various embodiments may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity, and should not be interpreted as an inflexible limitation on the scope of the present disclosure. Thus, the description of a range should be considered to have all possible subranges and individual numerical values ​​within that range specifically disclosed. For example, a description of a range such as 1-6 should be considered to have specifically disclosed subranges such as 1-3, 1-4, 1-5, 2-4, 2-6, 3-6, and individual numerical values ​​within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the scope of the range.

[0024] As used herein, the term "about" when referring to a number refers to a number plus or minus 20% of that number. The term "about" when referring to a range refers to a range from -20% of the lowest value to +20% of the highest value.

[0025] As used herein, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. For example, the term "sample" includes a plurality of samples, including mixtures thereof.

[0026] As used herein, the term "approximately D-shaped" means that the approximately straight sides of the "D" shape are arcs with a radius of curvature that is substantially greater (e.g., at least 1.1 times) than the radius of curvature of the arc of the "D". In some embodiments, the "D" shape is symmetrical about the anterior / posterior midline axis. In some embodiments, the "D" shape is asymmetrical about the lateral midline axis.

[0027] As used herein, the term "atrialisation" or "achieving atrialisation" refers to reducing the protrusion of a mitral valve prosthetic device into the ventricular cavity of the heart, thereby causing a reduction in the effect of such protrusion on the ventricular outflow or escape of the native leaflet, including displacement of the native mitral valve anterior leaflet to obstruct the left ventricular outflow trajectory. In some embodiments, the mitral valve prosthetic device has a stent frame assembly comprising a plurality of ventricular struts configured to protrude into the ventricular cavity of the heart. As used herein, the term "atrialisation" or "achieving atrialisation" also refers to reducing the protrusion of a plurality of ventricular struts into the ventricular cavity, thereby causing a reduction in the effect of such protrusion on the ventricular outflow or escape of the native leaflet. In some embodiments, the "atrialisation" of the prosthetic device also allows for full escape of the native leaflet (e.g. the native mitral valve anterior leaflet), thereby preserving the function of the native leaflet (e.g. the mitral valve anterior leaflet movement and associated valvular / ventricular interaction).

[0028] With regard to currently available bioprostheses for mitral valve replacement, the complete retention of the native mitral valve anterior leaflet (AML) at the time of mitral valve replacement is at risk of left ventricular outflow tract (LVOT) obstruction due to abnormal displacement of the native AML below the aortic valve. Displacement of the native AML occurs when the implanted bioprosthesis protrudes too far through the native mitral valve and into the ventricular cavity, limiting the complete prolapse of the native AML. However, aspects of the present disclosure provide a mitral valve prosthetic device that shows reduced protrusion into the ventricular cavity and will not allow the native AML to obstruct the LVOT, even if the native AML is not resected when the prosthetic device is implanted within the native mitral valve. In some embodiments, the mitral valve prosthetic device of the present disclosure is configured to augment the native mitral valve rather than replace it.

[0029] 1-4, an exemplary mitral valve prosthetic device 100 of the present disclosure is shown in various views. The mitral valve prosthetic device 100 has two ends, an atrial end configured to protrude into the atrial cavity of the heart and a ventricular end configured to protrude into the ventricular cavity of the heart when the prosthetic device 100 is implanted in the native mitral valve of the heart. FIGS. 1-2 are perspective and top plan views, respectively, depicting the ventricular end of the mitral valve prosthetic device 100 configured to protrude into the ventricular cavity of the heart. In some embodiments, the mitral valve prosthetic device 100 comprises a plurality of leaflets 110a, 110b, 110c fixedly coupled to a stent frame assembly 120, the leaflets protruding inwardly from the stent frame assembly 120 and occupying a central opening 122 of the stent frame assembly 120. Each leaflet has a free edge 116a, 116b, and 116c positioned adjacent one another and the free edges are not fixedly attached to the stent frame assembly 120. A central flow axis 124 extends through the central opening 122.

[0030] In some embodiments, the plurality of leaflets augment, support, or improve the function of the native mitral valve when the prosthetic device 100 is implanted within the native mitral valve. In some embodiments, the plurality of leaflets are configured to open in response to ventricular diastole and close in response to ventricular systole when the prosthetic device is implanted within the native mitral valve. In some embodiments, the plurality of leaflets are configured to allow blood flow from the atrial cavity to the ventricular cavity when the prosthetic device is implanted within the native mitral valve. In some embodiments, the plurality of leaflets are configured to restrict blood flow from the ventricular cavity to the atrial cavity when the prosthetic device is implanted within the native mitral valve. In some embodiments, the plurality of leaflets are configured to coapt in response to blood flow from the ventricular cavity to the atrial cavity when the prosthetic device is implanted within the native mitral valve. In some embodiments, each leaflet of the plurality of leaflets has a flexible membrane. In some embodiments, each leaflet of the plurality of leaflets is at least partially comprised of decellularized tissue or synthetic tissue. In some embodiments, each leaflet of the plurality of leaflets is comprised of a bioengineered material or tissue fixed in glutaraldehyde (e.g., bovine or porcine pericardium). In some embodiments, each leaflet of the plurality of leaflets is comprised of bovine or porcine pericardium. In some embodiments, each leaflet of the plurality of leaflets is comprised of a synthetic polymer (e.g., polyurethane, synthetic resin, thermoplastic elastomer). In some embodiments, each leaflet of the plurality of leaflets is coated with an anti-thrombotic agent. In some embodiments, each leaflet of the plurality of leaflets is coated with an anti-calcification agent. In some embodiments, each leaflet of the plurality of leaflets has anti-thrombotic properties, anti-calcification properties, or any combination thereof.

[0031] (Stent frame assembly) The mitral valve prosthetic device 100 comprises a stent frame assembly 120, which includes a cover 126 that surrounds the stent frame. In some embodiments, the cover 126 comprises an inner skirt and an outer skirt, which are attached or sewn to the stent frame.

[0032] The stent frame assembly 120 has two ends, an atrial end configured to protrude into the atrial cavity of the heart when the prosthetic device 100 is implanted within the native mitral valve of the heart, and a ventricular end configured to protrude into the ventricular cavity of the heart. In some embodiments, the atrial end of the stent frame assembly 120 is scalloped. In some embodiments, the ventricular end of the stent frame assembly 120 is scalloped.

[0033] In some embodiments, the stent frame assembly 120 is a non-circular shape. In some embodiments, the stent frame assembly 120 is approximately D-shaped (i.e., the approximately straight sides of the "D" shape are arcs with a radius of curvature that is substantially greater than the radius of curvature of the arc of the "D"). In some embodiments, the shape of the stent frame assembly 120 is symmetrical about the anterior / posterior midline axis. In some embodiments, the shape of the stent frame assembly 120 is asymmetrical about the lateral midline axis. In some embodiments, the stent frame assembly has a peripheral edge 128. In some embodiments, the shape of the peripheral edge 128 is non-circular. In some embodiments, the shape of the peripheral edge 128 is approximately D-shaped. In some embodiments, the shape of the peripheral edge 128 is symmetrical about the anterior / posterior midline axis. In some embodiments, the shape of the peripheral edge 128 is asymmetrical about the lateral midline axis.

[0034] (ventricular strut) In some embodiments, the stent frame assembly 120 includes a plurality of ventricular struts 140a, 140b, 140c. Each ventricular strut has a ventricular-facing lower end configured to protrude into the ventricular cavity when the prosthetic device 100 is implanted within the native mitral valve. In some embodiments, the plurality of ventricular struts includes a first anterior strut 140a, a second anterior strut 140b, and a posterior strut 140c.

[0035] In some embodiments, the anterior leaflet 110a is fixedly attached to the first anterior strut 140a and the second anterior strut 140b. In some embodiments, the first posterior leaflet 110b is fixedly attached to the second anterior strut 140b and the posterior strut 140c. In some embodiments, the second posterior leaflet 110c is fixedly attached to the posterior strut 140c and the first anterior strut 140a. In some embodiments, the anterior leaflet 110a, the first posterior leaflet 110b, the second posterior leaflet 110c, or any combination thereof, have a flexible membrane. In some embodiments, the anterior leaflet, the first posterior leaflet, the second posterior leaflet, or any combination thereof, are at least partially comprised of decellularized tissue or synthetic tissue.

[0036] In some embodiments, the anterior leaflet 110a is larger than each of the first and second posterior leaflets 110b, 110c. In some embodiments, the angle along the free edge of the anterior leaflet 116a is greater than each angle along the free edge of the first posterior leaflet 116b and each angle along the free edge of the second posterior leaflet 116c.

[0037] (peripheral ring) In some embodiments, a peripheral ring 150 surrounds the central opening 122 and is fixedly attached to the stent frame assembly 120. In some embodiments, the peripheral ring 150 contacts the peripheral edge 128 of the stent frame assembly 120. In some embodiments, the peripheral ring 150 is joined to or sewn to the stent frame assembly 120 with sutures.

[0038] In some embodiments, the peripheral ring 150 is a sewing ring. In some embodiments, the peripheral ring or sewing ring provides a platform through which an attachment structure (e.g., sutures, staples, clips, or fasteners) can be passed to secure the prosthetic device 100 to the native mitral annulus. The peripheral ring or sewing ring can be made thinner or thicker in diameter to accommodate different sewing techniques and does not affect the hemodynamic performance of the prosthetic device. In some embodiments, a metal wire is inside the peripheral ring or sewing ring to aid in visualization of the prosthetic device 100 under imaging. In some embodiments, the peripheral ring or sewing ring includes one or more layers. In some embodiments, the peripheral ring or sewing ring includes one or more fabrics.

[0039] In some embodiments, the peripheral ring 150 is configured to fit snugly over the native mitral annulus of the native mitral valve when the prosthetic device 100 is implanted within a subject's native mitral valve. In some embodiments, the peripheral ring 150 is shaped to match the shape of the native mitral annulus such that the prosthetic device 100 fits snugly over the native mitral annulus when the prosthetic device 100 is implanted within the native mitral annulus. In some embodiments, the peripheral ring 150 is flexible in the plane of the native mitral annulus. In some embodiments, the peripheral ring 150 is more flexible in the plane of the native mitral annulus than in a plane lateral to the plane of the native mitral annulus.

[0040] In some embodiments, the peripheral ring 150 is non-circular in shape. In some embodiments, the peripheral ring is approximately D-shaped (i.e., the approximately straight sides of the "D" shape are arcs with a radius of curvature that is substantially greater than the radius of curvature of the arc of the "D"). In some embodiments, the shape of the peripheral ring 150 is symmetrical about the anterior / posterior midline axis. In some embodiments, the shape of the peripheral ring 150 is asymmetrical about the lateral midline axis. In some embodiments, the peripheral ring 150 has the same shape as the peripheral edge 128 of the stent frame assembly. In some embodiments, the peripheral ring 150 has a peripheral edge 151. In some embodiments, the peripheral edge 151 of the peripheral ring 150 and the peripheral edge 128 of the stent frame assembly 120 have the same shape. In some embodiments, the peripheral edge 151 of the peripheral ring 150 is approximately D-shaped. In some embodiments, the shape of the peripheral edge 151 of the peripheral ring 150 is symmetrical about the anterior / posterior midline axis. In some embodiments, the shape of the peripheral edge 151 of the peripheral ring 150 is asymmetric about the lateral midline axis.

[0041] FIG. 2 depicts a top plan view of the mitral valve prosthetic device of FIG. 1 demonstrating the approximate “D” shape of the peripheral ring 150 , peripheral edge 151 , and peripheral edge 128 of the stent frame assembly 120 .

[0042] As a non-limiting example, measurements of an exemplary peripheral ring of an exemplary device can be taken, the exemplary device corresponding to a circular valve device of about 31 mm diameter. The exemplary peripheral ring 150 can have an outer anterior / posterior (AP) diameter of about 39.8 mm. The exemplary peripheral ring 150 can have an outer transverse diameter of about 47.1 mm. The exemplary peripheral ring 150 can have an inner anterior / posterior (AP) diameter of about 26.4 mm. The exemplary peripheral ring 150 can have an inner transverse diameter of about 32.6 mm. The exemplary peripheral ring can be made thinner or thicker from such dimensions to suit different sewing techniques. Although such an exemplary device is described as having a periphery corresponding to that of a heart valve device having a circular stent frame of 31 mm diameter, the devices of the present disclosure can be similarly compatible with other sized stent frames, for example those having circular valve diameters of about 20 mm to about 40 mm diameter.

[0043] In some embodiments, the peripheral edge 151 of the peripheral ring has a first leading corner 253a, a second leading corner 253b, and a trailing corner 253c. In some embodiments, the first leading post 140a is positioned at the first leading corner 253a, the second leading post 140b is positioned at the second leading corner 253b, and the trailing post 140c is positioned at the trailing corner 253c.

[0044] In some embodiments, the peripheral ring peripheral edge 151 has a leading edge 255a, which is positioned between the first and second anterior horns 253a, 253b. In some embodiments, the peripheral ring 150 has a first trailing edge 255b, which is positioned between the second anterior horn 253b and the posterior horn 253c. In some embodiments, the peripheral ring 150 has a second trailing edge 255c, which is positioned between the posterior horn 253c and the first anterior horn 253a. In some embodiments, the leading edge 255a, the first trailing edge 255b, and the second trailing edge 255c of the peripheral ring 150 are sized and shaped to match complementary portions of the native mitral annulus. In some embodiments, the leading edge 255a is flatter, longer, or flatter and longer than each of the first and second trailing edges 255b, 255c.

[0045] In some embodiments, the leading edge 255a is longer than each of the first and second trailing edges 255b and 255c.

[0046] (valve cusp) In some embodiments, each leaflet of the plurality of leaflets 110a, 110b, and 110c has a fixation edge coupled to the stent frame assembly 120. In some embodiments, the anterior leaflet 110a has a fixation edge 217a supported by the first anterior strut 140a and the second anterior strut 140b. In some embodiments, the first posterior leaflet 110b has a fixation edge 217b supported by the second anterior strut 140b and the posterior strut 140c. In some embodiments, the second posterior leaflet 110c has a fixation edge 217c supported by the posterior strut 140c and the first anterior strut 140a.

[0047] In some embodiments, the anterior leaflet 110a is fixedly attached to the stent frame assembly 120 adjacent a leading edge 253a of the peripheral ring 150. In some embodiments, the first posterior leaflet 110b is fixedly attached to the stent frame assembly 120 adjacent a first trailing edge 253b of the peripheral ring 150. In some embodiments, the second posterior leaflet 110c is fixedly attached to the stent frame assembly 120 adjacent a second trailing edge 253c of the peripheral ring 150.

[0048] In some embodiments, the anterior leaflet 110a is larger than each of the first and second posterior leaflets 110b and 110c. In some embodiments, the distance 244a between the first anterior strut 140a and the second anterior strut 140b is greater than the distances 244b and 244c between each anterior strut and the posterior strut 140c. In some embodiments, the ratio of the distance 244a between the first and second anterior struts to the sum of the distances 244a, 244b, and 244c is greater than 0.33. In some embodiments, the ratio of the distance 244a between the first and second anterior struts to the sum of the distances 244a, 244b, and 244c is about 0.4. In some embodiments, the ratio of the distance 244a between the first and second anterior struts to the sum of the distances 244a, 244b, and 244c is about 0.35 to about 0.45.

[0049] (Atrial and Ventricular Portions of the Stent Frame Assembly) 3 depicts an elevational view of the mitral valve prosthetic device 100. In some embodiments, the stent frame assembly 120 has an atrium-facing atrial portion 360 and a ventricle-facing ventricular portion 370. In some embodiments, the central opening 122 traverses between the atrial and ventricular portions. In some embodiments, the stent frame assembly 120 is configured such that when the prosthetic device 100 is implanted within a native mitral valve or on the atrial-facing side of the native mitral valve annulus, the atrial portion 360 is positioned within the atrial chamber of the heart and the ventricular portion 370 is positioned within the ventricular chamber of the heart.

[0050] In some embodiments, the atrial portion 360 is scalloped. In some embodiments, the ventricular portion 360 is scalloped. In some embodiments, the peripheral ring 150 is scalloped in the atrioventricular direction.

[0051] In some embodiments, the atrial portion 360 includes an atrial-facing upper end 362. In some embodiments, the ventricular portion 370 includes a ventricular-facing lower end 372. In some embodiments, the stent frame assembly 120 has a height 329 measured between the upper end 362 and the lower end 372.

[0052] As a non-limiting example, measurements of the atrial portion of an exemplary device can be taken, where the exemplary device corresponds to a circular valve device of approximately 31 mm diameter. In some embodiments, height 329, measured between upper end 362 and lower end 372, is approximately 16.3 mm. In some embodiments, height 329 is between approximately 12 mm and approximately 20 mm. In some embodiments, height 329 is between approximately 12 mm and approximately 14 mm, between approximately 14 mm and approximately 16 mm, between approximately 16 mm and approximately 18 mm, or between approximately 18 mm and approximately 20 mm. In some embodiments, the height 329 is about 12 mm, about 12.2 mm, about 12.4 mm, about 12.6 mm, about 12.8 mm, about 13 mm, about 13.2 mm, about 13.4 mm, about 13.6 mm, about 13.8 mm, about 14 mm, about 14.2 mm, about 14.4 mm, about 14.6 mm, about 14.8 mm, about 15 mm, about 15.2 mm, about 15.4 mm, about 15.6 mm, about 15.8 mm, about 15.9 mm, about 15.1 mm, about 15.2 mm, about 15.4 mm, about 15.6 mm, about 15.8 mm, about 15.9 mm, about 15.1 mm, about 15.2 mm, about 15.4 mm, about 15.6 mm, about 15.8 mm, about 15.1 mm, about 15.2 mm, about 15.4 mm, about 15.6 mm, about 15.8 mm, about 15.1 mm, about 15.2 mm, about 15.4 mm, about 15.6 mm, about 15.8 mm, about 15.1 mm, about 15.2 mm, about 15.2 mm, about 15.4 mm, about 15.6 mm, about 15.2 ... 0.8mm, about 16mm, about 16.2mm, about 16.4mm, about 16.6mm, about 16.8mm, about 17mm, about 17.2mm, about 17.4mm, about 17.6mm, about 17.8mm, about 18mm, about 18.2mm, about 18.4mm, about 18.6mm, about 18.8mm, about 19mm, about 19.2mm, about 19.4mm, about 19.6mm, about 19.8mm, or about 20mm.

[0053] In some embodiments, the ventricular section 370 includes multiple ventricular struts 140a, 140b, 140c. In some embodiments, the first anterior strut 140a has a ventricular-facing lower strut end 342a. In some embodiments, the second anterior strut 140b has a ventricular-facing lower strut end 342b. In some embodiments, the posterior strut 140c has a ventricular-facing lower strut end 342c. In some embodiments, the lower end 372 of the ventricular section 370 is one of the lower strut ends 342a, 342b, 342c. In some embodiments, the height 329 is measured between the upper end 362 and one of the lower strut ends 342a, 342b, 342c.

[0054] In some embodiments, the peripheral ring 150 is disposed between the atrial portion 360 and the ventricular portion 370. In some embodiments, the peripheral ring 150 positions the ventricular portion 370 of the stent frame assembly 120 on the mitral valve annulus such that protrusion of the stent frame assembly into the ventricular cavity is reduced. In some embodiments, the peripheral ring 150 positions the ventricular portion 370 of the stent frame assembly 120 on the mitral valve annulus such that protrusion of the stent frame assembly into the ventricular cavity and the effect of such protrusion on ventricular outflow or escape of the native leaflets is reduced.

[0055] In some embodiments, the peripheral ring 150 positions the ventricular portion 370 of the stent frame assembly 120 on the mitral valve annulus such that protrusion of the ventricular struts 140a, 140b, 140c into the ventricular cavity is reduced. In some embodiments, the peripheral ring 150 positions the ventricular portion 370 of the stent frame assembly 120 on the mitral valve annulus such that protrusion of the ventricular struts 140a, 140b, 140c into the ventricular cavity is reduced, as well as the effect of such protrusion on ventricular outflow or escape of the native leaflets.

[0056] In some embodiments, the peripheral ring 150 positions the ventricular portion 370 of the stent frame assembly 120 on the mitral valve annulus such that protrusion of the first and second anterior struts 140a, 140b into the ventricular cavity is reduced. In some embodiments, the peripheral ring 150 positions the ventricular portion 370 of the stent frame assembly 120 on the mitral valve annulus such that protrusion of the first and second anterior struts 140a, 140b into the ventricular cavity is reduced, as is the effect of such protrusion on ventricular outflow or escape of the native leaflets.

[0057] In some embodiments, the peripheral ring 150 has an atrium-facing uppermost surface 356 and a ventricle-facing lowermost surface 357. In some embodiments, the ventricle-facing lowermost surface 357 is configured to fit snugly over the native mitral valve annulus when the prosthetic device 100 is implanted within the native mitral valve. In some embodiments, the lowermost surface 357 contacts the atrium-facing side of the native mitral valve annulus.

[0058] (Ventricular length of stent frame assembly) In some embodiments, the ventricular portion 370 has a ventricular length 374 measured between a lowermost surface 357 of the peripheral ring 150 and a lower end 372 of the stent frame assembly 120. In some embodiments, the ventricular length 374 is less than about 66% of the height 329 of the stent frame assembly 120. In some embodiments, the ventricular length 374 is less than about 50% of the height 329 of the stent frame assembly 120. In some embodiments, the ventricular length 374 is less than about 33% of the height 329 of the stent frame assembly 120. In some embodiments, the ventricular length 374 and / or the height 329 are measured at the anterior side of the valve prosthesis 100.

[0059] In some embodiments, the ventricular length 374 is less than about 66%, less than about 64%, less than about 62%, less than about 60%, less than about 58%, less than about 56%, less than about 54%, less than about 52%, less than about 50%, less than about 48%, less than about 46%, less than about 44%, less than about 42%, less than about 40%, less than about 38%, less than about 36%, less than about 34%, less than about 32%, less than about 30%, less than about 28%, less than about 26%, less than about 24%, less than about 22%, less than about 20%, less than about 18%, or less than about 16% of the height 329 of the stent frame assembly 120.

[0060] As a non-limiting example, a measurement of the ventricular length of the exemplary device can be made, where the exemplary device corresponds to a circular valve device with a diameter of about 31 mm. In some embodiments, the ventricular length 374 is less than about 10 mm. In some embodiments, the ventricular length 374 is less than about 8.8 mm. In some embodiments, the ventricular length 374 is less than about 5.2 mm. In some embodiments, the ventricular length 374 is less than about 10 mm, less than about 9.5 mm, less than about 9 mm, less than about 8.5 mm, less than about 8 mm, less than about 7.5 mm, less than about 7 mm, less than about 6.5 mm, less than about 6 mm, less than about 5.5 mm, less than about 5 mm, less than about 4.5 mm, less than about 4 mm, less than about 3.5 mm, less than about 3 mm, less than about 2.5 mm, less than about 2 mm, or less than about 1.5 mm.

[0061] In some embodiments, the ratio of ventricular length 374 to height 329 of the stent frame assembly 120 is less than 13:20, less than 12:20, less than 11:20, less than 10:20, less than 9:20, less than 8:20, less than 7:20, less than 6:20, less than 5:20, less than 4:20, or less than 3:20. In some embodiments, the ratio of ventricular length 374 to height 329 of the stent frame assembly 120 is less than 2:3, less than 1:2, or less than 1:3.

[0062] In some embodiments, the ventricular length 374 is about 15% to about 65% of the height 329 of the stent frame assembly 120. In some embodiments, the ventricular length 374 is about 15% to about 20%, about 20% to about 25%, about 25% to about 30%, about 30% to about 35%, about 35% to about 40%, about 40% to about 45%, about 45% to about 50%, about 50% to about 55%, about 55% to about 60%, or about 60% to about 65% of the height 329 of the stent frame assembly 120.

[0063] By way of non-limiting example, a measurement of the ventricular length of an exemplary device can be made, where the exemplary device corresponds to a circular valve device of approximately 31 mm diameter. In some embodiments, the ventricular length 374 is approximately 5.2 mm. In some embodiments, the ventricular length 374 is approximately 8.8 mm. In some embodiments, the ventricular length 374 is approximately 1.5 mm to approximately 10 mm. In some embodiments, the ventricular length 374 is from about 1.5 mm to about 2 mm, from about 2 mm to about 2.5 mm, from about 2.5 mm to about 3 mm, from about 3 mm to about 3.5 mm, from about 3.5 mm to about 4 mm, from about 4 mm to about 4.5 mm, from about 4.5 mm to about 5 mm, from about 5 mm to about 5.5 mm, from about 5.5 mm to about 6 mm, from about 6 mm to about 6.5 mm, from about 6.5 mm to about 7 mm, from about 7 mm to about 7.5 mm, from about 7.5 mm to about 8 mm, from about 8 mm to about 8.5 mm, from about 8.5 mm to about 9 mm, from about 9 mm to about 9.5 mm, or from about 9.5 mm to about 10 mm.

[0064] In some embodiments, the ventricular length 374 is about 1.6 mm, about 1.8 mm, about 2 mm, about 2.2 mm, about 2.4 mm, about 2.6 mm, about 2.8 mm, about 3 mm, about 3.2 mm, about 3.4 mm, about 3.6 mm, about 3.8 mm, about 4 mm, about 4.2 mm, about 4.4 mm, about 4.6 mm, about 4.8 mm, about 5 mm, about 5.2 mm, about 5.4 mm, about 5.6 mm, about 5.8 mm, about 5.9 mm, about 6.0 mm, about 6.1 mm, about 6.2 mm, about 6.3 mm, about 6.4 mm, about 6.5 mm, about 6.6 mm, about 6.7 mm, about 6.8 mm, about 6.9 mm, about 7.0 mm, about 7.1 mm, about 7.2 mm, about 7.4 mm, about 7.5 mm, about 7.6 mm, about 7.8 mm, about 7.9 ... .6mm, about 5.8mm, about 6mm, about 6.2mm, about 6.4mm, about 6.6mm, about 6.8mm, about 7mm, about 7.2mm, about 7.4mm, about 7.6mm, about 7.8mm, about 8mm, about 8.2mm, about 8.4mm, about 8.6mm, about 8.8mm, about 9mm, about 9.2mm, about 9.4mm, about 9.6mm, about 9.8mm, or about 10mm.

[0065] In some embodiments, the ratio of the ventricular length 374 of the stent frame assembly 120 to the height 329 is about 7:20. In some embodiments, the ratio of the ventricular length 374 of the stent frame assembly 120 to the height 329 is about 11:20. In some embodiments, the ratio of the ventricular length 374 of the stent frame assembly 120 to the height 329 is between 3:20 and 13:20. In some embodiments, the ratio of the ventricular length 374 of the stent frame assembly 120 to the height 329 is about 3:20, about 4:20, about 5:20, about 6:20, about 7:20, about 8:20, about 9:20, about 10:20, about 11:20, about 12:20, or about 13:20. In some embodiments, the ratio of the ventricular length 374 of the stent frame assembly 120 to the height 329 is about 1:3, about 1:2, or about 2:3.

[0066] (Atrial length of stent frame assembly) In some embodiments, the atrial portion 360 has an atrial length 364 measured between a lowermost surface 357 of the peripheral ring 150 and an upper end 362 of the stent frame assembly 120. In some embodiments, the atrial length 364 is greater than about 33% of the height 329 of the stent frame assembly 120. In some embodiments, the atrial length 364 is greater than about 50% of the height 329 of the stent frame assembly 120. In some embodiments, the atrial length 364 is greater than about 66% of the height 329 of the stent frame assembly 120. In some embodiments, the atrial length 364 and / or the height 329 are measured anterior to the valve prosthesis 100.

[0067] In some embodiments, the atrial length 364 is greater than about 34%, greater than about 36%, greater than about 38%, greater than about 40%, greater than about 42%, greater than about 44%, greater than about 46%, greater than about 48%, greater than about 50%, greater than about 52%, greater than about 54%, greater than about 56%, greater than about 60%, greater than about 62%, greater than about 64%, greater than about 66%, greater than about 68%, greater than about 70%, greater than about 72%, greater than about 74%, greater than about 76%, greater than about 78%, greater than about 80%, greater than about 82%, or greater than about 84% of the height 329 of the stent frame assembly 120.

[0068] As a non-limiting example, atrial length measurements of an exemplary device can be made, where the exemplary device corresponds to a circular valve device of about 31 mm diameter. In some embodiments, the atrial length 364 is greater than about 6 mm. In some embodiments, the atrial length 364 is greater than about 7.5 mm or greater. In some embodiments, the atrial length 364 is greater than about 11.1 mm or greater. In some embodiments, the atrial length 364 is greater than about 6 mm, greater than about 6.5 mm, greater than about 7 mm, greater than about 7.5 mm, greater than about 8 mm, greater than about 8.5 mm, greater than about 9 mm, greater than about 9.5 mm, greater than about 10 mm, greater than about 10.5 mm, greater than about 11 mm, greater than about 11.5 mm, greater than about 12 mm, greater than about 12.5 mm, greater than about 13 mm, greater than about 13.5 mm, or greater than about 14 mm.

[0069] In some embodiments, the atrial length 364 is about 35% to about 85% of the height 329 of the stent frame assembly 120. In some embodiments, the atrial length 364 is about 35% to about 40%, about 40% to about 45%, about 45% to about 50%, about 50% to about 55%, about 55% to about 60%, about 60% to about 65%, about 65% to about 70%, about 70% to about 75%, about 75% to about 80%, or about 80% to about 85% of the height 329 of the stent frame assembly 120.

[0070] By way of non-limiting example, a measurement of the atrial length of an exemplary device can be made, where the exemplary device corresponds to a circular valve device having a diameter of about 31 mm. In some embodiments, the atrial length 364 is about 7.5 mm. In some embodiments, the atrial length 364 is about 11.1 mm. In some embodiments, the atrial length 364 is about 6 mm to about 14 mm. In some embodiments, the atrial length 364 is between about 6 mm and about 6.5 mm, between about 6.5 mm and about 7 mm, between about 7 mm and about 7.5 mm, between about 7.5 mm and about 8 mm, between about 8 mm and about 8.5 mm, between about 8.5 mm and about 9 mm, between about 9 mm and about 9.5 mm, between about 9.5 mm and about 10 mm, between about 10 mm and about 10.5 mm, between about 10.5 mm and about 11 mm, between about 11 mm and about 11.5 mm, between about 11.5 mm and about 12 mm, between about 12 mm and about 12.5 mm, between about 12.5 mm and about 13 mm, between about 13 mm and about 13.5 mm, or between about 13.5 mm and about 14 mm.

[0071] In some embodiments, the atrial length 364 is about 6 mm, about 6.2 mm, about 6.4 mm, about 6.6 mm, about 6.8 mm, about 7 mm, about 7.2 mm, about 7.4 mm, about 7.6 mm, about 7.8 mm, about 8 mm, about 8.2 mm, about 8.4 mm, about 8.6 mm, about 8.8 mm, about 9 mm, about 9.2 mm, about 9.4 mm, about 9.6 mm, about 9.8 mm, about 10 mm , about 10.2 mm, about 10.4 mm, about 10.6 mm, about 10.8 mm, about 11 mm, about 11.2 mm, about 11.4 mm, about 11.6 mm, about 11.8 mm, about 12 mm, about 12.2 mm, about 12.4 mm, about 12.6 mm, about 12.8 mm, about 13 mm, about 13.2 mm, about 13.4 mm, about 13.6 mm, about 13.8 mm, or about 14 mm.

[0072] 4 is a perspective view of the atrial end of the mitral valve prosthetic device 100 of the present disclosure configured to protrude into the atrial cavity. In some embodiments, the atrial end of the stent frame assembly 120 is scalloped. In some embodiments, the atrial end of the stent frame assembly has multiple scallop tips 465a, 465b, and 465c. In some embodiments, each scallop tip is approximately flush with the peripheral ring 150.

[0073] In some embodiments, the plurality of leaflets 140a, 140b, and 140c define a first anterior commissure 418a between adjacent free edges of the anterior leaflet 110a and the first posterior leaflet 110b, a second anterior commissure 418b between adjacent free edges of the anterior leaflet 110a and the second posterior leaflet 110c, and a posterior commissure 418c between adjacent free edges of the first posterior leaflet 110b and the second posterior leaflet 110c.

[0074] (Stent frame) In some embodiments, the stent frame assembly comprises a stent frame. FIG. 5 is a perspective view of a stent frame 530 of an exemplary mitral valve prosthetic device 100 of the present disclosure. In some embodiments, the stent frame 530 is non-circular in shape. In some embodiments, the stent frame 530 is approximately D-shaped (i.e., the approximately straight sides of the "D" shape are arcs with a radius of curvature that is substantially greater than the radius of curvature of the arc of the "D"). In some embodiments, the shape of the stent frame 530 is symmetrical about the anterior / posterior midline axis. In some embodiments, the shape of the stent frame 530 is asymmetrical about the lateral midline axis. In some embodiments, the stent frame 530 is configured to fit inside the peripheral ring of the prosthetic device.

[0075] In some embodiments, the stent frame 530 is made of a biocompatible material (e.g., metal or plastic), hi some embodiments, the stent frame 530 is made of stainless steel, Elgiloy, Delrin, or a biocompatible plastic (e.g., polyethylene, PEEK, and similar materials).

[0076] In some embodiments, the stent frame 530 has multiple suture holes 531. In some embodiments, the multiple suture holes 531 are used to securely connect the multiple leaflets to the stent frame assembly with sutures. In some embodiments, the multiple suture holes 531 are used to attach the peripheral ring to the stent frame assembly with sutures. In some embodiments, the multiple suture holes 531 are used to attach the cover to the stent frame 530 with sutures. In some embodiments, the suture holes are used for assembly of the stent frame assembly 120 and for attaching the peripheral ring 150 to the stent frame assembly. In some embodiments, multiple suture lines can pass through the holes of the multiple suture holes. In some embodiments, at least two of the multiple leaflets, peripheral ring, or cover can be attached to the stent frame in sequence, with multiple suture lines passing through one of the multiple suture holes or one of the multiple suture holes being passed multiple times.

[0077] In some embodiments, the stent frame 530 has an inner front frame edge 533a and an outer front frame edge 535a. In some embodiments, the stent frame 530 has an inner first rear frame edge 533b and an outer first rear frame edge 535b. In some embodiments, the stent frame 530 has an inner second rear frame edge 533c and an outer second rear frame edge 535c. In some embodiments, the inner front frame edge 533a is flatter, longer, or flatter and longer than each of the inner first rear frame edge 533b and the inner second rear frame edge 533c. In some embodiments, the outer front frame edge 535a is flatter, longer, or flatter and longer than each of the outer first rear frame edge 535b and the outer second rear frame edge 535c.

[0078] In some embodiments, the outer frame edges 535a, 535b, and 535c are defined by a peripheral ring or peripheral edges of a peripheral ring that surrounds the stent frame 530 or stent frame assembly.

[0079] In some embodiments, the stent frame 530 has multiple frame struts 540a, 540b, 540c, each extending from a ventricular end 581 of the cylinder 580. In some embodiments, the central flow axis 124 extends through the cylinder 580. In some embodiments, the cylinder is an asymmetric cylinder. In some embodiments, the cylinder 580 has a non-circular cross-section. In some embodiments, the cylinder 580 has a cross-section that is approximately D-shaped. In some embodiments, the cross-section of the cylinder 580 is symmetric about the anterior / posterior midline axis. In some embodiments, the cross-section of the cylinder 580 is asymmetric about the lateral midline axis. In some embodiments, the cross-section of the cylinder 580 and the peripheral edge 128 of the stent frame assembly 120 have the same shape.

[0080] Each frame strut of the plurality of frame struts has a ventricular-facing lower end configured to protrude into the ventricular cavity when the prosthetic device 100 is implanted within the native mitral valve. In some embodiments, the plurality of frame struts includes a first anterior frame strut 540a, a second anterior frame strut 540b, and a posterior frame strut 540c.

[0081] In some embodiments, the first anterior frame strut 540a is configured to fixedly attach the anterior leaflet and the second posterior leaflet to the stent frame 530. In some embodiments, the second anterior frame strut 540b is configured to fixedly attach the anterior leaflet and the first posterior leaflet. In some embodiments, the posterior frame strut 540c is configured to fixedly attach the first and second posterior leaflets to the stent frame 530.

[0082] Figure 6A is an elevational view of the stent frame of Figure 5. Figure 6B is a cross-sectional view taken along the section line indicated in Figure 6A.

[0083] In some embodiments, the cylinder 580 has two ends: an atrial end configured to protrude into the atrial cavity of the heart when the prosthetic device 100 is implanted within the native mitral valve of the heart, and a ventricular end 581 that abuts the multiple frame struts 540a, 540b, and 540c. In some embodiments, the cylinder 580 has an uppermost atrial end 582.

[0084] In some embodiments, the stent frame 530 has an overall height 639, which may be measured from the top end 582 of the cylinder 580 to the bottom end of one or more of the frame struts 540a, 540b, and 540c.

[0085] As a non-limiting example, a measurement of the overall height 639 of the stent frame of an exemplary device can be taken, where the exemplary device corresponds to a circular valve device of about 31 mm diameter. In some embodiments, the overall height 639 is about 16.3 mm. In some embodiments, the overall height 639 is about 12 mm to about 20 mm. In some embodiments, the overall height 639 is about 12 mm to about 14 mm, about 14 mm to about 16 mm, about 16 mm to about 18 mm, or about 18 mm to about 20 mm. In some embodiments, the overall height 639 is about 12 mm, about 12.2 mm, about 12.4 mm, about 12.6 mm, about 12.8 mm, about 13 mm, about 13.2 mm, about 13.4 mm, about 13.6 mm, about 13.8 mm, about 14 mm, about 14.2 mm, about 14.4 mm, about 14.6 mm, about 14.8 mm, about 15 mm, about 15.2 mm, about 15.4 mm, about 15.6 mm, about 15.8 mm, about 15.9 mm, about 15.1 ... 0.8mm, about 16mm, about 16.2mm, about 16.4mm, about 16.6mm, about 16.8mm, about 17mm, about 17.2mm, about 17.4mm, about 17.6mm, about 17.8mm, about 18mm, about 18.2mm, about 18.4mm, about 18.6mm, about 18.8mm, about 19mm, about 19.2mm, about 19.4mm, about 19.6mm, about 19.8mm, or about 20mm.

[0086] In some embodiments, frame strut height 674 can be measured from the ventricular end 581 of cylinder 580 to the bottom end of one or more of frame struts 540a, 540b, and 540c. In some embodiments, frame strut height 674 is the same regardless of whether it is measured from the bottom end of frame struts 540a, 540b, or 540c.

[0087] As a non-limiting example, a measurement of the frame post height 674 of an exemplary device can be made, where the exemplary device corresponds to a circular valve device of about 31 mm diameter. In some embodiments, the frame post height 674 is about 5.2 mm. In some embodiments, the frame post height 674 is about 8.8 mm. In some embodiments, the frame post height 674 is about 1.5 mm to about 10 mm. In some embodiments, the frame post height 674 is between about 1.5 mm and about 2 mm, between about 2 mm and about 2.5 mm, between about 2.5 mm and about 3 mm, between about 3 mm and about 3.5 mm, between about 3.5 mm and about 4 mm, between about 4 mm and about 4.5 mm, between about 4.5 mm and about 5 mm, between about 5 mm and about 5.5 mm, between about 5.5 mm and about 6 mm, between about 6 mm and about 6.5 mm, between about 6.5 mm and about 7 mm, between about 7 mm and about 7.5 mm, between about 7.5 mm and about 8 mm, between about 8 mm and about 8.5 mm, between about 8.5 mm and about 9 mm, between about 9 mm and about 9.5 mm, or between about 9.5 mm and about 10 mm.

[0088] In some embodiments, the frame post height 674 is about 1.6 mm, about 1.8 mm, about 2 mm, about 2.2 mm, about 2.4 mm, about 2.6 mm, about 2.8 mm, about 3 mm, about 3.2 mm, about 3.4 mm, about 3.6 mm, about 3.8 mm, about 4 mm, about 4.2 mm, about 4.4 mm, about 4.6 mm, about 4.8 mm, about 5 mm, about 5.2 mm, about 5.4 mm, about 5.6 mm, about 5.8 mm, about 6 mm, about 6.2 mm, about 6.4 mm, about 6.6 mm, about 6.8 mm, about 7 mm, about 7.2 mm, about 7.4 mm, about 7.6 mm, about 7.8 mm, about 8 mm, about 8.2 mm, about 8.4 mm, about 8.6 mm, about 8.8 mm, about 9 mm, about 9.2 mm, about 9.4 mm, about 9.6 mm, about 9.8 mm, or about 10 mm.

[0089] As a non-limiting example, a measurement of the frame strut height 674 of an exemplary device can be made, where the exemplary device corresponds to a circular valve device of about 31 mm diameter. In some embodiments, the frame strut height 674 is less than about 10 mm. In some embodiments, the frame strut height 674 is less than about 8.8 mm. In some embodiments, the frame strut height 674 is less than about 5.2 mm. In some embodiments, the frame strut height 674 is less than about 10 mm, less than about 9.5 mm, less than about 9 mm, less than about 8.5 mm, less than about 8 mm, less than about 7.5 mm, less than about 7 mm, less than about 6.5 mm, less than about 6 mm, less than about 5.5 mm, less than about 5 mm, less than about 4.5 mm, less than about 4 mm, less than about 3.5 mm, less than about 3 mm, less than about 2.5 mm, less than about 2 mm, or less than about 1.5 mm.

[0090] In some embodiments, the cylinder 580 has a cylinder height 684 as measured from the uppermost atrial end 582 to the ventricular end 581 of the cylinder.

[0091] As a non-limiting example, a measurement of the cylindrical height 684 of an exemplary device can be made, where the exemplary device corresponds to a circular valve device of about 31 mm diameter. In some embodiments, the cylindrical height 684 is about 7.5 mm. In some embodiments, the cylindrical height 684 is about 11.1 mm. In some embodiments, the cylindrical height 684 is about 6 mm to about 14 mm. In some embodiments, the cylinder height 684 is about 6 mm to about 6.5 mm, about 6.5 mm to about 7 mm, about 7 mm to about 7.5 mm, about 7.5 mm to about 8 mm, about 8 mm to about 8.5 mm, about 8.5 mm to about 9 mm, about 9 mm to about 9.5 mm, about 9.5 mm to about 10 mm, about 10 mm to about 10.5 mm, about 10.5 mm to about 11 mm, about 11 mm to about 11.5 mm, about 11.5 mm to about 12 mm, about 12 mm to about 12.5 mm, about 12.5 mm to about 13 mm, about 13 mm to about 13.5 mm, or about 13.5 mm to about 14 mm.

[0092] In some embodiments, the cylinder height 684 is about 6 mm, about 6.2 mm, about 6.4 mm, about 6.6 mm, about 6.8 mm, about 7 mm, about 7.2 mm, about 7.4 mm, about 7.6 mm, about 7.8 mm, about 8 mm, about 8.2 mm, about 8.4 mm, about 8.6 mm, about 8.8 mm, about 9 mm, about 9.2 mm, about 9.4 mm, about 9.6 mm, about 9.8 mm, about 10 mm , about 10.2 mm, about 10.4 mm, about 10.6 mm, about 10.8 mm, about 11 mm, about 11.2 mm, about 11.4 mm, about 11.6 mm, about 11.8 mm, about 12 mm, about 12.2 mm, about 12.4 mm, about 12.6 mm, about 12.8 mm, about 13 mm, about 13.2 mm, about 13.4 mm, about 13.6 mm, about 13.8 mm, or about 14 mm.

[0093] As a non-limiting example, a measurement of the cylindrical height 684 of an exemplary device can be made, where the exemplary device corresponds to a circular valve device of about 31 mm diameter. In some embodiments, the cylindrical height 684 is greater than about 6 mm. In some embodiments, the cylindrical height 684 is greater than about 7.5 mm or greater. In some embodiments, the cylindrical height 684 is greater than about 11.1 mm or greater. In some embodiments, the cylindrical height 684 is greater than about 6 mm, greater than about 6.5 mm, greater than about 7 mm, greater than about 7.5 mm, greater than about 8 mm, greater than about 8.5 mm, greater than about 9 mm, greater than about 9.5 mm, greater than about 10 mm, greater than about 10.5 mm, greater than about 11 mm, greater than about 11.5 mm, greater than about 12 mm, greater than about 12.5 mm, greater than about 13 mm, greater than about 13.5 mm, or greater than about 14 mm.

[0094] In certain embodiments, the atrial end of the cylinder 580 is scalloped. In some embodiments, the atrial end of the cylinder 580 has a scallop tip 583. In some embodiments, the atrial end of the cylinder 580 has multiple scallop tips. In some embodiments, a scallop height 689 is measured from the uppermost atrial end 582 to the scallop tip 583.

[0095] In some embodiments, the scallop height 689 is about 4.9 mm. In some embodiments, the scallop height 689 is about 7.2 mm. In some embodiments, the scallop height 689 is between about 3 mm and about 10 mm.

[0096] In some embodiments, the width between the outer and inner frame edges (e.g., outer frame edge 535a and inner frame edge 533a), as depicted in the cross-sectional view of FIG. 6B and the plan view of the stent frame depicted in FIG. 7A, defines a wall thickness 638. In some embodiments, wall thickness 638 is about 1.8 mm. In some embodiments, wall thickness 638 is about 0.5 mm to about 5 mm.

[0097] (Stent frame diameter and dimensions) Figures 7A-7C depict plan views of the stent frame of Figure 5. Figures 7A and 7B depict an anterior / posterior (AP) axis 705 that intersects with a transverse axis 707 at an intersection 709. The stent frame 530 has at least two diameters in each axial direction that result from the wall thickness 638 of the stent frame.

[0098] In some embodiments, the stent frame 530 has an inner anterior / posterior (AP) diameter 791 along the AP axis 705, the inner AP diameter 791 being measured from an inner frame edge of the stent frame 530. In some embodiments, the stent frame 530 has an outer AP diameter 793 along the AP axis 705, the outer AP diameter 793 being measured from an outer frame edge of the stent frame 530.

[0099] In some embodiments, the stent frame 530 has an inner transverse diameter 794 along the transverse axis 707, the inner transverse diameter 794 being measured from an inner frame edge of the stent frame 530. In some embodiments, the stent frame 530 has an outer transverse diameter 796 along the transverse axis 707, the outer transverse diameter 796 being measured from an outer frame edge of the stent frame 530.

[0100] As a non-limiting example, measurements of the stent frame 530 of an exemplary device can be taken, the exemplary device corresponding to a circular valve device of about 31 mm diameter. The inner AP diameter 791 can be about 25 mm or about 20 mm to about 30 mm. The outer AP diameter 793 can be about 29 mm or about 24 mm to about 34 mm. The inner transverse diameter 794 can be about 30 mm or about 25 mm to about 35 mm. The outer transverse diameter 796 can be about 34 mm or about 29 mm to about 39 mm.

[0101] In some embodiments, the first front angle 701 exists between a first reference line 741a and a second reference line 741b, where the first reference line 741a extends from the intersection point 709 through the first front frame pillar 540a and the second reference line 741b extends from the intersection point 709 through the second front frame pillar 540b.

[0102] In some embodiments, the first front angle 701 is between about 140 degrees and about 164 degrees. In some embodiments, the first front angle 701 is about 153 degrees.

[0103] In some embodiments, the first front angle 701 is greater than 140 degrees, greater than 142 degrees, greater than 144 degrees, greater than 146 degrees, greater than 148 degrees, greater than 150 degrees, or greater than 152 degrees.

[0104] In some embodiments, the first P1 angle 703a exists between the second reference line 741b and the AP axis 705. In some embodiments, the first P2 angle 703b exists between the first reference line 741a and the AP axis 705.

[0105] In some embodiments, the first P1 angle 703a is between about 90 degrees and about 110 degrees. In some embodiments, the first P1 angle 703a is about 103 degrees.

[0106] In some embodiments, the first P2 angle 703b is between about 90 degrees and about 110 degrees. In some embodiments, the first P2 angle 703b is about 103 degrees.

[0107] In some embodiments, the sum of the first P1 angle 703a and the first P2 angle 703b is between about 196 degrees and about 220 degrees. In some embodiments, the sum of the first P1 angle 703a and the first P2 angle 703b is less than 214 degrees, less than 212 degrees, less than 210 degrees, less than 208 degrees, less than 206 degrees, less than 204 degrees, less than 202 degrees, or less than 200 degrees.

[0108] FIG. 7C depicts a center point 708 defined by the intersection of a first line 706a, a second line 706b, and a third line 706c, where the first line 706a is perpendicular to a first tangent line 745a tangent to frame post 540a, the second line 706b is perpendicular to a second tangent line 745b tangent to frame post 540b, and the third line 706c is perpendicular to a third tangent line 745c tangent to frame post 540c.

[0109] In some embodiments, the second front angle 702 lies between the first line 706a and the second line 706b. In some embodiments, the second P1 704a angle lies between the second line 706b and the third line 706c. In some embodiments, the second P2 angle 704b lies between the third line 706c and the first line 706a.

[0110] (Stent frame cover) FIG. 8 is a cross-sectional view of the assembled mitral valve prosthetic device 100 taken along the cross-sectional view shown in FIG.

[0111] In some embodiments, the stent frame assembly 120 comprises a cover 126 disposed over the stent frame 530. In some embodiments, the cover 126 comprises an inner skirt 825 and an outer skirt 827. In some embodiments, at least one of the cover, the inner skirt, or the outer skirt comprises fabric or pericardial tissue.

[0112] In some embodiments, the peripheral ring 150 comprises an inner fabric 852 and an outer fabric 854. In some embodiments, the peripheral ring is made of at least one of a woven polyester fabric (e.g., polyethylene terephthalate or polyester), silk, polypropylene, other fiber or fabric materials, silicone, PET, or expanded PTFE. In some embodiments, the peripheral ring comprises a metal wire 858, which allows visualization of the prosthetic device 100 under imaging. In some embodiments, a fabric cover encapsulates the metal wire.

[0113] In some embodiments, the fixing edge 217a of the leaflet 110a is attached to the stent frame 530 by passing a suture through a plurality of suture holes 531. In some embodiments, the covering 126 (e.g., the inner skirt 825 and / or the outer skirt 827) is attached to the stent frame 530 by passing a suture through a plurality of suture holes 531.

[0114] (Alternate mounting location for perimeter ring) 9A-9B are elevational views of a stent frame depicting variations in the attachment locations of the peripheral rings to the stent frame. The attachment location 959a depicted in FIG. 9A achieves a higher degree of atrialization compared to either attachment location 959b and 959c, as depicted in FIG. 9B. In some embodiments, the peripheral ring's ventricular-facing lowermost surface 957a is positioned farther from the uppermost atrial end 582 of the cylinder 580 than the ventricular end 581 of the cylinder. In some embodiments, the peripheral ring's atrial-facing uppermost surface 956a is approximately horizontally aligned with the surface of the scallop tip 583.

[0115] Attachment location 959c achieves the least degree of atrialization compared to attachment locations 959a and 959b. In some embodiments, the peripheral ring's lowermost ventricular-facing surface 957c is positioned closer to the uppermost atrial end 582 of the cylinder 580 than the ventricular end 581 of the cylinder.

[0116] Attachment location 959b has some degree of atrialization between attachment locations 959a and 959c. Attachment location 959b represents a "horizontal" or "flat" position of the peripheral ring, where the ventricular-facing, lowermost surface 957b of the peripheral ring is aligned with the horizontal surface of the ventricular end 581 of the cylinder.

[0117] (Complete or partial saddle-shaping of the peripheral ring) In some embodiments, the peripheral ring has a flat (i.e., horizontal) configuration. In some embodiments, atrialization can be achieved or improved by giving the peripheral ring a partially saddled or fully saddled configuration. In some embodiments, the peripheral ring 1050 can be saddle-shaped (e.g., fully saddled configuration) such that the peripheral ring is closer to the scallops of the atrial end of the anterior cylinder 580 along the AP diameter and closer to the scallops of the atrial end of the cylinder 580 along the lateral diameter, as depicted in FIG. 10. In some embodiments, the various suture holes on the cylinder 580 can be shifted to better align with or follow the fully saddled peripheral ring 1050 on the cylinder.

[0118] In some embodiments, the peripheral ring 1050 can be saddle-shaped (e.g., a first partially saddle-shaped configuration) such that the peripheral ring is closer to the scallops of the atrial end of the anterior cylinder 580 along the AP diameter and the peripheral ring is horizontal or flat posterior to the AP diameter. In some embodiments, the peripheral ring 1050 can be saddle-shaped (e.g., a second partially saddle-shaped configuration) such that the peripheral ring is closer to the scallops of the atrial end of the anterior cylinder 580 along the AP diameter and the peripheral ring is horizontal or flat posterior to the AP diameter and the peripheral ring is also horizontal or flat along the lateral diameter, as depicted in FIG. 10. In some embodiments, the various suture holes on the cylinder 580 can be shifted to better align with or follow the partially saddle-shaped peripheral ring 1050 on the cylinder.

[0119] Complete or partial saddle-shaping can achieve or improve atrialization because the ventricular end 581 of the cylinder is inversely scalloped toward the lowermost surface of the peripheral ring 1050 adjacent the ventricular end 581, thereby causing the shape of the ventricular end 581 of the cylinder to align with or follow the shape of the saddle-like peripheral ring 1050, thereby preventing most of the total area of ​​the stent frame 530 from protruding into the ventricular cavity.

[0120] (Atrialization of mitral valve prosthetic devices achieved by implantation method) The native mitral valve separates the atrial (i.e., left atrium LA) and ventricular (i.e., left ventricle LV) chambers of the heart. The native mitral valve annulus has an atrium-facing side and a ventricular-facing side. In some embodiments, atrialization can be achieved or improved by implanting a mitral valve prosthetic device in the atrial-facing side of the native mitral valve annulus. FIG. 11 depicts the placement of an exemplary mitral valve prosthetic device 100 into the native mitral valve annulus MV in a manner that achieves atrialization. In some embodiments, a higher degree of atrialization of the prosthetic device 100 is achieved by sewing a peripheral ring to the atrial-facing side of the native mitral valve annulus, thereby reducing the protrusion of the prosthetic device 100 (e.g., multiple ventricular struts 140a, 140b, and 140c) into the ventricular cavity, as depicted in FIG. 11. Achieving a higher degree of atrialization can reduce the impact of the native anterior leaflets of the native mitral valve caused by such protrusion on ventricular outflow (e.g., LVOT obstruction) or prolapse, since the native anterior leaflets are not or minimally displaced below the aortic valve by the prosthetic device 100. With a higher degree of atrialization, the native anterior leaflets of the mitral valve do not need to be resected or modified, and thus can continue to maintain the structure of the left ventricle in addition to the chordae CH and the papillary muscles PM, thereby maintaining their natural support for left ventricular function. Furthermore, with a higher degree of atrialization, the impact of the native leaflets on prolapse (e.g., protrusion of the stent frame assembly into the ventricular cavity causing limited or submaximal prolapse) will be reduced.

[0121] In some embodiments, standard suture implantation techniques can be applied when implanting the prosthetic device 100, including sewing the peripheral ring 150 to the atrial side of the mitral annulus with a first suture line, and then suturing the peripheral ring to the mitral valve wall with a second suture line. In some embodiments, a continuous gusset stitch (e.g., an overlock stitch) can be used for the second suture line. In some embodiments, adding a second suture line helps to cover any resulting gaps at the junction of the sewing ring with the atrial wall or annulus, thereby further preventing the risks associated with stasis and thrombogenicity.

[0122] In some embodiments, the first anterior strut 140a and the second anterior strut 140b are positioned adjacent the anterior side of the native mitral valve annulus when implanting the prosthetic device 100. In some embodiments, the posterior strut 140c is positioned adjacent the posterior side of the native mitral valve annulus.

[0123] (Atrialization of a Mitral Valve Prosthetic Device Achieved by Peripheral Ring Scalloping) 12A-12D are various views depicting an alternative version of the atrialization, an exemplary mitral valve prosthetic device 1200 of the present disclosure includes a peripheral ring 1205 with scalloping toward the ventricular-facing ends 1210 of the ventricular struts. FIGs. 13A-13B depict elevational and cross-sectional views, respectively, of the stent frame 1215 of the exemplary mitral valve prosthetic device 1200 depicted in FIGs. 12A-12D. FIG. 13A shows the overall height 1220, strut height 1225, cylinder height 1230, and scallop height 1235 of the stent frame. FIG. 13B shows a cross-sectional view of the stent frame 1215 taken along line 13B in FIG. 13A.

[0124] In some embodiments, atrialization is achieved by modifying the ratio of cylinder height to total height compared to the embodiments shown above. In some embodiments, the sewing ring is scalloped in the ventricular direction along each ventricular strut of the stent frame assembly. Such scalloping significantly reduces the ventricular length of the stent frame assembly, thereby reducing the protrusion of the stent frame assembly into the ventricular cavity. In some embodiments, the lowermost surface of the peripheral ring can be measured from the scalloped portion of the peripheral ring.

[0125] The devices described herein can also be applicable to other heart valves, such as the tricuspid valve. In some embodiments, the heart valve prosthetic device is configured to augment, support, or improve the function of the native tricuspid valve when the prosthetic device is implanted within the native tricuspid valve.

[0126] Although preferred embodiments of the present disclosure have been shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided by way of example only. The present disclosure is not intended to be limited by the specific examples provided herein. Although embodiments of the present disclosure have been described with reference to the foregoing specification, the descriptions and illustrations of the embodiments herein are not meant to be construed in a limiting sense. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the scope of the present disclosure. Furthermore, it should be understood that all aspects of the present disclosure are not limited to the specific depictions, configurations, or relative proportions described herein which depend upon a variety of conditions and variables. It should be understood that various alternatives to the embodiments of the present disclosure described herein may be employed in practicing the embodiments of the present disclosure. It is therefore contemplated that the present disclosure also covers any such alternatives, modifications, variations, or equivalents. It is intended that the following claims define the scope of the present invention, and that methods and structures within the scope of these claims and their equivalents are thereby covered.

Claims

1. 1. A heart valve prosthesis device, comprising: a stent frame assembly having an atrial portion including an upper end facing the atrium, a ventricular portion including a lower end facing the ventricle, a height between said upper and lower ends, and a central opening traversing between said atrial and ventricular portions; a peripheral ring attached to the stent frame assembly and surrounding the central opening, the peripheral ring being disposed between the atrial and ventricular portions, the peripheral ring having a ventricular-facing inferior surface configured to fit snugly over a native heart valve annulus when the prosthetic device is implanted within the native heart valve; a plurality of leaflets fixedly coupled to the stent frame assembly and positioned in the central opening of the stent frame assembly; Equipped with A heart valve prosthetic device in which the peripheral ring limits the protrusion of the stent frame assembly into the ventricular cavity, thereby reducing the effect of such protrusion on ventricular outflow or prolapse of the native cusps.

2. The heart valve prosthesis device of claim 1 , wherein the heart valve prosthesis device is a mitral valve prosthesis device.

3. 10. The heart valve prosthetic device according to any one of the preceding claims, wherein the native heart valve annulus is a native mitral valve annulus.

4. 10. The heart valve prosthesis device according to any one of the preceding claims, wherein the native heart valve is a native mitral valve.

5. The heart valve prosthesis device of claim 1 , wherein the heart valve prosthesis device is a tricuspid valve prosthesis device.

6. 6. The heart valve prosthetic device according to claim 1 or 5, wherein the native heart valve annulus is a native tricuspid annulus and the native heart valve is a native tricuspid valve.

7. 2. The heart valve prosthesis device according to claim 1, wherein a ventricular length between the lowermost surface of the peripheral ring and the lower end of the stent frame assembly is less than 66% of the height between the lower end and the upper end of the stent frame assembly.

8. 2. The heart valve prosthesis device according to claim 1, wherein a ventricular length between the lowermost surface of the peripheral ring and the lower end of the stent frame assembly is less than 50% of the height between the lower end and the upper end of the stent frame assembly.

9. 2. The heart valve prosthesis device according to claim 1, wherein a ventricular length between the lowermost surface of the peripheral ring and the lower end of the stent frame assembly is less than 33% of the height between the lower end and the upper end of the stent frame assembly.

10. 2. The heart valve prosthesis device according to any one of the preceding claims, wherein the ventricular length between the lowermost surface of the peripheral ring and the lower end of the stent frame assembly is less than or equal to 8 mm.

11. 2. The heart valve prosthesis device according to any one of the preceding claims, wherein the ventricular length between the lowermost surface of the peripheral ring and the lower end of the stent frame assembly is 5 mm or less.

12. The heart valve prosthesis device according to any one of claims 7 to 11, wherein the ventricular length is measured at the anterior side of the stent frame assembly.

13. 2. The heart valve prosthesis device according to claim 1, wherein an atrial length between the lowermost surface of the peripheral ring and the upper end of the stent frame assembly is greater than 33% of the height between the lower and upper ends of the stent frame assembly.

14. 2. The heart valve prosthesis device according to claim 1, wherein an atrial length between the lowermost surface of the peripheral ring and the upper end of the stent frame assembly is greater than 50% of the height between the lower and upper ends of the stent frame assembly.

15. 2. The heart valve prosthesis device according to claim 1, wherein an atrial length between the lowermost surface of the peripheral ring and the upper end of the stent frame assembly is greater than 66% of the height between the lower and upper ends of the stent frame assembly.

16. The heart valve prosthesis device according to any one of claims 13-15, wherein the height between the lower end and the upper end of the stent frame assembly is measured from the front side of the stent frame assembly.

17. 10. The heart valve prosthetic device of claim 9, wherein each leaflet comprises a flexible membrane, and the leaflets are configured to open in response to ventricular diastole and close in response to ventricular systole when the prosthetic device is implanted within the native mitral valve.

18. 10. The heart valve prosthetic device according to claim 9, wherein the leaflets are configured to permit blood flow from the atrium to the ventricle and restrict blood flow from the ventricular cavity to the atrial cavity when the prosthetic device is implanted within the native heart valve.

19. 2. The heart valve prosthetic device according to claim 1, wherein the leaflets are configured to coapt to one another in response to blood flow from a ventricular chamber to the atrial chamber when the prosthetic device is implanted within the native heart valve.

20. 2. The heart valve prosthesis device of claim 1, wherein the leaflets are at least partially composed of decellularized or synthetic tissue.

21. 2. The heart valve prosthesis device according to any one of the preceding claims, wherein the stent frame assembly comprises a stent frame and a cover disposed over the stent frame.

22. 22. The heart valve prosthesis device of claim 21, wherein the covering comprises fabric or pericardial tissue.

23. 10. The heart valve prosthesis device according to any one of the preceding claims, wherein the stent frame assembly has a height of between 12mm and 20mm.

24. 10. The heart valve prosthesis device according to any one of the preceding claims, wherein the atrial portion has a height of between 6 mm and 14 mm.

25. 20. The heart valve prosthesis device according to any one of the preceding claims, wherein the ventricular portion has a height of between 1.5 mm and 10 mm.

26. 10. The heart valve prosthetic device according to claim 1, wherein the peripheral ring is shaped to conform to the shape of the native mitral valve annulus so as to fit snugly over the native mitral valve annulus when the prosthetic device is implanted within the native mitral valve.

27. 2. The heart valve prosthesis device of claim 1, wherein the stent frame assembly has an anterior-posterior diameter and a transverse diameter, the anterior-posterior diameter being smaller than the transverse diameter.

28. 10. The heart valve prosthesis device of claim 9, wherein the stent frame assembly has a leading edge, a first trailing edge, and a second trailing edge, the leading edge being flatter, longer, or flatter and longer than each of the first and second trailing edges.

29. 30. The heart valve prosthesis device of claim 28, wherein a leading edge, a first trailing edge, and a second trailing edge of the stent frame assembly are defined by the peripheral ring.

30. 10. The heart valve prosthesis device according to any one of the preceding claims, wherein the stent frame assembly has an anterior-posterior diameter of between 20mm and 34mm.

31. 10. The heart valve prosthesis device according to any one of the preceding claims, wherein the stent frame assembly has a transverse diameter of between 25mm and 39mm.

32. 2. The heart valve prosthesis device according to any one of the preceding claims, wherein the stent frame assembly is of a non-circular shape.

33. 2. The heart valve prosthesis device according to any one of the preceding claims, wherein the stent frame assembly is approximately D-shaped.

34. 10. The heart valve prosthesis device according to any one of the preceding claims, wherein the peripheral ring is scalloped in the atrioventricular direction.

35. 2. The heart valve prosthesis device according to any one of the preceding claims, wherein the peripheral ring is of a non-circular shape.

36. 2. The heart valve prosthesis device according to any one of the preceding claims, wherein the peripheral ring is approximately D-shaped.

37. 2. The heart valve prosthesis device according to any one of the preceding claims, wherein the peripheral edges of the stent frame assembly and the peripheral ring have the same shape.

38. 10. The heart valve prosthesis device according to any one of the preceding claims, wherein the peripheral ring comprises a metal wire to aid in visualization of the heart valve prosthesis device under imaging.

39. 10. The heart valve prosthesis device of claim 9, wherein the peripheral ring comprises a leading edge, a first trailing edge, and a second trailing edge, each sized and shaped to match a complementary portion of the native valve annulus.

40. 40. The heart valve prosthesis device of claim 39, wherein the peripheral ring further comprises a first anterior corner, a second anterior corner, and a posterior corner, the anterior edge being positioned between the first and second anterior corners, the first posterior edge being positioned between the second anterior corner and the posterior corner, and the second posterior edge being positioned between the posterior corner and the first anterior corner.

41. 41. The heart valve prosthesis device of claim 39 or 40, wherein the leading edge is flatter, longer, or flatter and longer than each of the first and second trailing edges.

42. 42. The heart valve prosthesis device of any one of claims 39-41, wherein the plurality of leaflets comprises an anterior leaflet fixedly attached to the stent frame assembly adjacent the leading edge of the peripheral ring.

43. 43. The heart valve prosthesis device of claim 39, wherein the plurality of leaflets comprises a first posterior leaflet fixedly attached to the stent frame assembly adjacent the first trailing edge of the peripheral ring, and a second posterior leaflet fixedly attached to the stent frame assembly adjacent the second trailing edge of the peripheral ring.

44. 2. The heart valve prosthesis device of any one of the preceding claims, wherein the stent frame assembly comprises an asymmetric cylinder and a plurality of ventricular struts extending therefrom.

45. 45. The heart valve prosthesis device of claim 44, wherein the peripheral ring further comprises a first anterior horn, a second anterior horn, and a posterior horn, and the plurality of ventricular struts comprises a first anterior strut positioned at the first anterior horn, a second anterior strut positioned at the second anterior horn, and a posterior strut positioned at the posterior horn.

46. 10. The heart valve prosthesis device according to any one of the preceding claims, wherein the atrial end of the stent frame assembly is scalloped.

47. 10. The heart valve prosthesis device according to any one of the preceding claims, wherein the ventricular end of the stent frame assembly is scalloped.

48. 10. The heart valve prosthesis device according to any one of the preceding claims, wherein the peripheral ring is a sewing ring.

49. 10. The heart valve prosthetic device according to any one of the preceding claims, wherein the peripheral ring is flexible in the plane of the native heart valve annulus.

50. 50. The heart valve prosthetic device of claim 49, wherein the peripheral ring is more flexible in the plane of the native heart valve annulus than in a plane transverse to the plane of the native heart valve annulus.

51. 2. The heart valve prosthesis device of claim 1, wherein the plurality of leaflets comprises an anterior leaflet, a first posterior leaflet, and a second posterior leaflet, each having a fixed edge and a free edge coupled to the stent frame assembly.

52. 52. The heart valve prosthetic device of claim 51, wherein the anterior leaflet is larger than each of the first and second posterior leaflets.

53. 53. The heart valve prosthesis device of claim 51 or 52, wherein the stent frame assembly comprises a plurality of ventricular struts, the plurality of ventricular struts comprising a first anterior strut, a second anterior strut, and a posterior strut.

54. 54. The heart valve prosthesis device of claim 53, wherein a fixation edge of the anterior leaflet is supported by the first and second anterior struts, and the distance between the first and second anterior struts exceeds the distance between each anterior strut and the posterior strut.

55. A heart valve prosthetic device as described in any one of claims 51-54, wherein the angle along the free edge of the anterior leaflet exceeds each angle along the free edge of the first posterior leaflet and each angle along the free edge of the second posterior leaflet.

56. The heart valve prosthetic device of any one of claims 51-55, wherein the plurality of leaflets are arranged to define a first anterior commissure between adjacent free edges of the anterior leaflet and the first posterior leaflet, a second anterior commissure between adjacent free edges of the anterior leaflet and the second posterior leaflet, and a posterior commissure between adjacent free edges of the first posterior leaflet and the second posterior leaflet.

57. 10. The heart valve prosthetic device according to any one of the preceding claims, wherein the heart valve prosthetic device is configured to augment the native heart valve.

58. 1. A method for treating a heart valve insufficiency, comprising: The method includes implanting a stent frame assembly of a heart valve prosthesis device within a native heart valve of the heart; whereby a ventricular-facing lowermost surface of a peripheral ring coupled to the stent frame assembly fits snugly over the annulus of the native heart valve, the peripheral ring separating the stent frame assembly into an atrial portion and a ventricular portion; The peripheral ring limits protrusion of the stent frame assembly into the ventricular cavity and reduces the effect of such protrusion on ventricular outflow or prolapse of the native apex.

59. 59. The method of claim 58, wherein the heart valve is a mitral valve.

60. 60. The method of claim 58 or 59, wherein the heart valve prosthetic device is a mitral valve prosthetic device.

61. 61. The method of any one of claims 58-60, wherein the native heart valve is a native mitral valve.

62. 59. The method of claim 58, wherein the heart valve prosthetic device is a tricuspid valve prosthetic device.

63. 63. The method of claim 58 or 62, wherein the native heart valve annulus is a native tricuspid annulus and the native heart valve is a native tricuspid valve.

64. The method of any one of claims 58-63, wherein the ventricular length between the lowermost surface of the peripheral ring and the lower end of the stent frame assembly is less than 66% of the height between the lower and upper ends of the stent frame assembly.

65. 65. The method of any one of claims 58-64, wherein a ventricular length between the lowermost surface of the peripheral ring and the lower end of the stent frame assembly is less than 50% of the height between the lower end and the upper end of the stent frame assembly.

66. 66. The method of any one of claims 58-65, wherein a ventricular length between the lowermost surface of the peripheral ring and the lower end of the stent frame assembly is less than 33% of the height between the lower end and the upper end of the stent frame assembly.

67. 67. The method of any one of claims 58-66, wherein the ventricular length between the lowermost surface of the peripheral ring and the lower end of the stent frame assembly is 8 mm or less.

68. The method of any one of claims 58-67, wherein the ventricular length between the lowermost surface of the peripheral ring and the lower end of the stent frame assembly is 5 mm or less.

69. The method of any one of claims 59-68, wherein the ventricular length is measured anterior to the stent frame assembly.

70. 70. The method of any one of claims 58-69, wherein an atrial length between the lowermost surface of the peripheral ring and the upper end of the stent frame assembly is greater than 33% of the height between the lower and upper ends of the stent frame assembly.

71. 71. The method of any one of claims 58-70, wherein an atrial length between the lowermost surface of the peripheral ring and the upper end of the stent frame assembly is greater than 50% of the height between the lower and upper ends of the stent frame assembly.

72. 72. The method of any one of claims 58-71, wherein an atrial length between the lowermost surface of the peripheral ring and the upper end of the stent frame assembly is greater than 66% of the height between the lower and upper ends of the stent frame assembly.

73. The method of any one of claims 69-72, wherein the height between the lower end and the upper end of the stent frame assembly is measured from a front side of the stent frame assembly.

74. The method of any one of claims 58-73, wherein the heart valve prosthetic device is configured to augment the native heart valve.

75. The method of any one of claims 58-74, wherein the stent frame assembly is implanted within the native heart valve annulus with the native anterior heart valve leaflets preserved.

76. The method of any one of claims 58-75, wherein the stent frame assembly is implanted within the native heart valve annulus without the native anterior heart valve leaflets being resected or remodeled.

77. The method of any one of claims 58-76, wherein the stent frame assembly is implanted within the native heart valve annulus without substantially any alteration of the anatomical position of the native anterior heart valve leaflets.

78. 78. The method according to any one of claims 58-77, wherein embedding the stent frame assembly within the native heart valve comprises positioning the stent frame assembly and a plurality of leaflets associated therewith such that a native anterior leaflet of the heart valve is not prevented from occupying the annulus of the native heart valve, at least in part, during ventricular systole.

79. 80. The method of claim 78, wherein each leaflet comprises a flexible membrane, and the plurality of leaflets are configured to open in response to ventricular diastole and close in response to ventricular systole when the prosthetic device is implanted within the native heart valve.

80. 80. The method of claim 78 or 79, wherein the plurality of valve leaflets are configured to allow blood flow from the atrium to the ventricle and restrict blood flow from the ventricular cavity to the atrial cavity when the prosthetic device is implanted within the native heart valve.

81. 81. The method of any one of claims 78-80, wherein the plurality of valve leaflets are configured to coapt to one another in response to blood flow from a ventricular chamber to the atrial chamber when the prosthetic device is implanted within the native heart valve.

82. The method of any one of claims 78-81, wherein the plurality of leaflets comprises an anterior leaflet, a first posterior leaflet, and a second posterior leaflet, each comprising a fixed edge coupled to the stent frame assembly and a free edge.

83. 83. The method of claim 82, wherein the anterior leaflet is larger than each of the first and second posterior leaflets.

84. The method of any one of claims 78-83, wherein the stent frame assembly comprises a plurality of ventricular struts, the plurality of ventricular struts comprising a first anterior strut, a second anterior strut, and a posterior strut.

85. 85. The method of claim 84, wherein a fixation edge of the anterior leaflet is supported by the first and second anterior struts, the distance between the first and second anterior struts being greater than the distance between each anterior strut and the posterior strut.

86. The method of any one of claims 58-85, wherein the stent frame assembly comprises a stent frame and a cover disposed over the stent frame.

87. 87. The method according to any one of claims 58-86, wherein the peripheral ring is shaped to conform to the shape of the native heart valve annulus so as to fit snugly over the native heart valve annulus when the heart valve prosthetic device is implanted within the native heart valve.

88. The method of any one of claims 58-87, wherein the stent frame assembly has a posterior-posterior diameter and a horizontal diameter, the posterior-posterior diameter being smaller than the horizontal diameter.

89. The method of any one of claims 58-88, wherein the stent frame assembly has a leading edge, a first trailing edge, and a second trailing edge, the first trailing edge being flatter, longer, or flatter and longer than each of the first and second trailing edges.

90. The method of any one of claims 58-89, wherein a leading edge, a first trailing edge, and a second trailing edge of the stent frame assembly are defined by the peripheral ring.

91. The method of any one of claims 58-90, wherein the stent frame assembly is non-circular in shape.

92. The method of any one of claims 58-91, wherein the stent frame assembly is approximately D-shaped.

93. The method of any one of claims 58-92, wherein the peripheral ring is non-circular in shape.

94. A method according to any one of claims 58-93, wherein the peripheral ring is approximately D-shaped.

95. 95. The method of any one of claims 58-94, wherein the peripheral ring is scalloped in the atrioventricular direction.

96. The method of any one of claims 58-95, wherein the peripheral edges of the stent frame assembly and the peripheral ring have the same shape.

97. The method of any one of claims 58-96, wherein the stent frame assembly comprises an asymmetric cylinder and a plurality of ventricular struts extending therefrom.

98. The method of any one of claims 58-97, wherein the atrial end of the stent frame assembly is scalloped.

99. The method of any one of claims 58-98, wherein the ventricular end of the stent frame assembly is scalloped.

100. The method of any one of claims 58-99, wherein the peripheral ring is a sewing ring.

101. The method of any one of claims 58-101, wherein the circumferential ring is flexible in the plane of the heart valve annulus.

102. 102. The method of claim 101, wherein the peripheral ring is more flexible in the plane of the native heart valve annulus than in a plane transverse to the plane of the native heart valve annulus.

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